Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4100](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4100) → KGY — Bag, Intestine

# KGY · Bag, Intestine

_General, Plastic Surgery · 21 CFR 878.4100 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY

## Overview

- **Product Code:** KGY
- **Device Name:** Bag, Intestine
- **Regulation:** [21 CFR 878.4100](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4100)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

An organ bag is a device that is a flexible plastic bag intended to be used as a temporary receptacle for an organ during surgical procedures to prevent moisture loss.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K933085](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY/K933085.md) | GOODMAN BANDAGE | Megadyne Medical Products, Inc. | Dec 23, 1993 | SESE |
| [K913678](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY/K913678.md) | TROCAR CATHETER | Medovations, Inc. | Dec 16, 1991 | SESE |
| [K910914](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY/K910914.md) | SURGICAL TISSUE POUCH | Cook Urological, Inc. | Mar 28, 1991 | SESE |
| [K832318](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY/K832318.md) | ISOLATION BAG 3M | 3M Company | Oct 31, 1983 | SESE |
| [K801824](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY/K801824.md) | BAND-AID BRAND FLEXIBLE FABRIC BANDAGE | Johnson & Johnson Professionals, Inc. | Aug 20, 1980 | SESE |
| [K801823](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY/K801823.md) | BAND-AID BRAND TRICOT MESH BANDAGES | Johnson & Johnson Professionals, Inc. | Aug 20, 1980 | SESE |

## Top Applicants

- Johnson & Johnson Professionals, Inc. — 2 clearances
- 3M Company — 1 clearance
- Cook Urological, Inc. — 1 clearance
- Medovations, Inc. — 1 clearance
- Megadyne Medical Products, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGY)

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